ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients 5.3: Calibrate critical control, weighing, measuring, monitoring and test equipment to a written schedule against traceable standards, and investigate out-of-calibration findings

What does 5.3 require?

Equipment critical to quality for control, weighing, measuring, monitoring and testing should be calibrated to written procedures and a set schedule, using standards traceable to certified standards where they exist, with records kept. The calibration status of each critical item should be known at any time and checkable, and instruments failing calibration criteria should not be used. Where a critical instrument is found outside its calibration standard, the possible effect on intermediates or APIs made with it since the last good calibration should be investigated.